Disproportionality Analysis of Oral Toxicities Associated with PI3K/AKT/mTOR Pathway Inhibitors Using the FAERS Database.

ABSTRACT: Background: Stomatitis is a common adverse event associated with targeted therapies for hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer, particularly those inhibiting the PI3K/AKT/mTOR pathway. While mTOR-inhibitor-associated stomatitis is well established, less is known about its occurrence with other kinase inhibitors in real-world settings. We performed a pharmacovigilance disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) to evaluate stomatitis reports for alpelisib, capivasertib, everolimus, and palbociclib. Methods: Events were identified using four term sets-Stomatitis, Original Trial Terms (OTT), Comprehensive Trial Terms (CTT), and Stomatitis-Associated Main Terms (SAMT)-which reflect varying definitions and medical termi

SUBMITTER: Marni M 

PROVIDER: S-EPMC12567227 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature